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A Multicenter, Randomized, Controlled, Open Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05
216
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug called B007 compared to cyclosporine in treating adults with primary membranous nephropathy, a kidney condition. This study is a multicenter, randomized, controlled, open-label trial conducted in phases II and III to better understand treatment options for this disease. Participants will be randomly assigned to receive either B007 or cyclosporin capsules. B007 is given by subcutaneous injection on days 1 and 15, while cyclosporin capsules are taken orally at a dose of 3.5 mg per kg of body weight per day. The study will observe participants over about two years to assess remission rates and monitor safety. During the trial, participants will undergo laboratory tests and assessments to track overall, complete, and partial remission rates. Researchers will also monitor any treatment-emergent adverse events or serious side effects. Participants must meet specific kidney function criteria and will be followed closely throughout the study period until its completion in late 2026.
CONDITIONS
Brief Title
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with primary membranous nephropathy confirmed by kidney biopsy
- Glomerular filtration rate (eGFR) of at least 45 mL/min/1.73 m2
- Stable dose of ACE inhibitors, angiotensin II receptor antagonists, sodium-glucose cotransporter 2 inhibitors, or endothelin inhibitors for at least 4 weeks before randomization
- Elevated 24-hour urinary protein meeting study conditions
- Laboratory test results within prescribed standards during screening
- Able to understand and voluntarily sign informed consent
- Able to follow the study protocol as judged by the investigator
You will not qualify if you...
- Secondary membranous nephropathy or primary membranous nephropathy with crescent bodies in pathology
- Previous resistance to CD20 monoclonal antibody or cyclosporine
- Prior use of medications prescribed for membranous nephropathy
- Presence of other prescribed diseases
- Known severe allergic reactions to humanized monoclonal antibodies or allergies to cyclosporine or B007 components
- Receipt of live vaccine, major surgery, or participation in other clinical trials within 28 days before study drug
- Positive hepatitis B surface antigen or hepatitis C virus antibody
- History of immunodeficiency or other acquired or congenital immunodeficiency diseases
- History of tuberculosis or prior anti-tuberculosis treatment
- CD4+ T lymphocyte count less than 400 cells/µL
- Pregnant or breastfeeding women; women of childbearing potential not agreeing to contraception during and 12 months after treatment
- Male subjects not agreeing to barrier contraception during and 12 months after treatment or not consenting to spouse contraception
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 years
Participants receive treatment with either B007 by subcutaneous injection on days 1 and 15 or Cyclosporin Capsules orally at 3.5 mg/kg per day.
Visits as needed for dosing and monitoring during treatment
Trial Site Locations
Total: 21 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, China
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2
Peking university first hospital
Beijing, China
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3
The Second Norman Bethune Hospital of Jilin University
Changchun, China
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4
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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5
Zhujiang Hospital of Southern Medical University
Guangzhou, China
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6
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, China
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7
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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8
Shandong Provincial Hospital
Jinan, China
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9
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
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10
Affiliated Hospital of Nantong University
Nantong, China
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11
The Affiliated Hospital of Qingdao University
Qingdao, China
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12
Northern Theater Command General Hospital
Shenyang, China
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13
Shengjing Hospital affiliated to China Medical University
Shenyang, China
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14
Peking University Shenzhen Hospital
Shenzhen, China
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15
Renmin Hospital of Wuhan University
Wuhan, China
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16
Wuxi People's Hospital
Wuxi, China
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17
Xi'an Daxing Hospital
Xi'an, China
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18
The Second Affiliated Hospital of Xingtai Medical college
Xingtai, China
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19
Northern Jiangsu People's Hospital
Yangzhou, China
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20
Yantai Yuhuangding Hospital
Yantai, China
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21
The First People's Hospital of Zigong
Zigong, China
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Research Team
M
Minghui Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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